Glioma Cancer Malignant neoplasm of brain
Conditions
Interventions
Current intervention as of 30/06/2022:
Research Pathway:
For patient’s undergoing surgery, fresh tissue will be collected from the patient’s initial surgery and frozen until shipment to the Oxford BRA
Sponsors
University of Birmingham
Eligibility
Sex/Gender
All
Age
16 Years to 120 Years
Inclusion criteria
Inclusion criteria: Current inclusion criteria as of 03/01/2024: 1. Any patient =16 years 2. Newly diagnosed suspected WHO Grade 2-4 glioma, (as evidenced radiologically) AND suitable for a diagnostic or therapeutic surgical procedure resulting in a tumour sample matched to a blood sample 3. Patients with progression with known WHO Grade 2-4 glioma (those with available frozen tumour will be prioritised for detailed genomic analysis) 4. Valid written informed consent for the study _____ Previous inclusion criteria from 07/01/2021 to 03/01/2024: 1. Newly diagnosed suspected WHO Grade 2-4 glioma, (as evidenced radiologically) AND suitable for a diagnostic or therapeutic surgical procedure resulting in a tumour sample matched to a blood sample 2. Patients with progression with known WHO Grade 2-4 glioma (those with available frozen tumour will be prioritised for detailed genomic analysis) 3. Valid written informed consent for the study _____ Original inclusion criteria: 1. Newly diagnosed suspected glioma, (as evidenced radiologically) AND suitable for a diagnostic or therapeutic surgical procedure resulting in a tumour sample matched to a blood sample 2. Patients with progression with known Grade 2-4 glioma (those with available frozen tumour will be prioritised for detailed genomic analysis) 3. Valid written informed consent for the study
Exclusion criteria
Exclusion criteria: 1. Primary spinal cord tumours 2. Active treatment of other malignancy 3. Contraindication to MRI 4. Patients without standard of care imaging available (added 07/01/2021)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current primary outcome measure as of 16/05/2025: 1. Time (from biopsy) to integrated histological–molecular diagnosis (TTMD) using standard of care NHS practice, defined as the difference (days) between date of biopsy and date of final local pathology report, measured within 28 days. 2. Time (from biopsy) to Whole Genome Sequencing report to the treating clinician using NHS Genomic Medicine Service, defined as the different (days) between date of biopsy and date that a patient's Genomic Tumour Advisory Board (GTAB) report is produced, measured within 28 days. _____ Previous primary outcome measure as of 30/06/2022: Time (from biopsy) to integrated histological–molecular diagnosis (TTMD), defined as the difference (days) between dates of biopsy and date of whole genome diagnosis and epigenomic classification, measured within 28 days. Previous primary outcome measure: Time (from biopsy) to integrated histological – molecular diagnosis (TTMD), defined as the difference (days) between dates of biopsy and whole genome diagnosis and epigenomic classification, measured within 28 days. | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 30/06/2022: Secondary outcome measures to be achieved within a timescale of up to 5 years: 1. Time to completion of each node of tissue and imaging pathway, measured from the date of receipt at the current node to date of delivery at the next. 2. Tumour and biological sample(s) quality control (QC) status: tumour and biological sample collection will be measured against protocol guidelines. These data will be collected in the surgical and pathological forms. 3. Imaging QC status: imaging will be measured against established clinical guideline. The imaging form will measure compliance against these guidelines. 4. Inter-rater agreement of Response Assessment in Neuro-Oncology (RANO): scans will be assessed and scored according to RANO criteria by the hub of Neuro-radiologists. Patient-centred outcome measures to be achieved within a timescale of up to 5 years: 1. Extent of surgical resection, evaluated from the post-operative MRI scan and categorised as follows: Closed biopsy, open biopsy, debulking <50%, subtotal resection 50-90%, near total resection 90-<100%, gross total resection 100%. 2. Overall survival time, defined as the time from date of diagnosis to the date of death. Patients who are alive at the time of analysis will be censored at the date last seen in clinic. 3. Intracranial progression-free survival time, defined as the time from date of registration to the earliest of date of intracranial progressive disease or death from disease. The date of an event is defined as the earliest confirmation of progression by radiological assessment, clinical symptoms or MDT. Patients without progression will be censored at the date last seen in clinic. 4. Quality of Life scores: longitudinal measures of QoL will be generated from the QoL questionnaire according to the questionnaire-specific algorithm for scoring. 5. Type of interventions received, monitored throughout the follow-up period and recorded on the CRF. 6. Type of c | — |
Countries
England, Scotland, United Kingdom, Wales
Outcome results
None listed